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Comparison of Vasodilator Response of Inhaled Epoprostenol and Inhaled Nitric Oxide

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04231084
Collaborator
(none)
108
Enrollment
1
Location
2
Arms
22.5
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The overarching goal of this study is to examine the acute vasoreactive response to both inhaled nitric oxide and inhaled epoprostenol across both traditionally and non-traditionally interrogated phenotypes in PH, and to further characterize the relationship of vasoreactivity to disease severity and PH phenotype.

Condition or Disease Intervention/Treatment Phase
  • Drug: Vasodilator testing (Inhaled Nitric Oxide)
  • Drug: Vasodilator testing (Inhaled Epoprostenol)
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Acute Hemodynamic Comparison of Inhaled Nitric Oxide and Inhaled Epoprostenol in Pulmonary Hypertension
Actual Study Start Date :
Jan 15, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Inhaled Nitric Oxide

Vasodilator testing will be performed with inhaled nitric oxide

Drug: Vasodilator testing (Inhaled Nitric Oxide)
Right heart catheterization with vasodilator testing with each arms' associated agent will be performed
Experimental: Inhaled Epoprostenol

Vasodilator testing will be performed with inhaled epoprostenol

Drug: Vasodilator testing (Inhaled Epoprostenol)
Right heart catheterization with vasodilator testing with each arms' associated agent will be performed

Outcome Measures

Primary Outcome Measures

  1. Change in mean pulmonary artery pressure [Pre-pulmonary vasodilator testing measurements (baseline) will be compared to post-pulmonary vasodilator testing measurements during diagnostic right heart catheterization.]

    The primary outcome will be change in mean pulmonary artery pressure (mmHg) from baseline to after 5-minutes of inhaled vasodilator.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • mPAP ≥ 21mmHg, PAWP ≤ 25mmHg, and PVR ≥3 WU

  • Classified as WHO group I-III pulmonary hypertension

Exclusion Criteria:

  • WHO group IV and V pulmonary hypertension

  • Patients who are on baseline pulmonary vasodilator medications

  • Severe aortic or mitral valve disease

  • Patients who are pregnant

  • Left ventricular ejection fraction of <35%

  • Patients who are hospitalized as inpatients at the time of RHC

  • Patients with systolic blood pressure <90mmHg or mean arterial pressure of < 60mmHg

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brigham and Women's Hospital Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Brigham and Women's Hospital

Investigators

  • Principal Investigator: Aaron B Waxman, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aaron Waxman MD PhD, Associate Professor of Pulmonary and Critical Care, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT04231084
Other Study ID Numbers:
  • 2019P003491
First Posted:
Jan 18, 2020
Last Update Posted:
Jan 31, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Epoprostenol
Nitric Oxide
Vasodilator Agents
Tezosentan

Study Results

No Results Posted as of Jan 31, 2022